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Recall Observatory FDA recall evidence

Device product

EVA Floor Lifts, Model Numbers: 400, 450, 600

Z-1943-2020

June 15, 2016

Class II

Product summary

Firm
Handicare AB
Event
Event 85362
Status
Ongoing
Classification
Class II
Quantity
997 units
Official record key
device-enforcement:Z-1943-2020

Official wording

Reason: After feedback from customers and internal suspicion, Handicare has become aware that abnormal use of Eva-lifts could lead to a deterioation in the joint of the liftarm. This could lead to injury if the joint breaks. All lifts must therefore be checked and reported back to the manuafacturer.

Code information: All affected models

Distribution pattern: US and Mexico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    After feedback from customers and internal suspicion, Handicare has become aware that abnormal use of Eva-lifts could lead to a deterioation in the joint of the liftarm. This could lead to injury if the joint breaks. All lifts must therefore be checked and reported back to the manuafacturer.